Normandie University, 14000, Caen, France.
UMR 1086 INSERM « ANTICIPE », 14000, Caen, France.
BMC Cancer. 2024 Sep 4;24(1):1097. doi: 10.1186/s12885-024-12521-1.
In oncology, the suffering of patients and the burnout of health professionals are key issues. Mindfulness meditation is a holistic approach that can help to improve well-being. While numerous studies have shown the benefits of meditation for both patients and health professionals, the added value of offering shared meditation to groups of patients, health professionals and third persons has not been assessed. Beyond strengthening the relationship between carers and patients, opening up meditation sessions to third parties (neither carers nor patients) enables patients to escape the stigma of their illness. We previously conducted a pilot study that validated the feasibility and the relevance of shared meditation with a specifically designed programme.
METHODS/DESIGN: IMPLIC-2 is a two-arm randomised study designed to assess the added value of this meditation programme (optimised following the pilot study), particularly for cancer patients (our target population). People motivated to follow the programme, without previous regular practice of meditation and able to participate in the sessions are eligible. The study will include 96 participants: 16 health professionals, 16 third persons and 64 patients. The latter will be randomized in two arms: the experimental arm ("Shared" meditation) consisting of 4 mixed groups of 8 patients, 4 health professionals and 4 third parties, and the control arm ("Patient" meditation) consisting of 2 groups of 16 patients. Validated questionnaires will be used to measure the effects of the programme, notably in terms of quality of life, perceived stress, feelings of self-efficacy, qualities of mindfulness and self-compassion, and carers' burn-out. Participants' perception of a change in their quality of life and satisfaction will be measured at the end of the programme. A complementary qualitative focus-group approach will be used to optimise implementation of the programme beyond the study.
The well-being of oncology patients would be improved. Dealing with overworked carers would have a beneficial impact on the way they interact with patients. In addition, encounters between the three types of population will allow otherness to be viewed differently and alleviate suffering by promoting collective humanity.
NCT06041607, registered: 09/18/2023.
Version n°1.2 dated from 08/29/2023.
在肿瘤学领域，患者的痛苦和医疗保健专业人员的倦怠是关键问题。正念冥想是一种整体方法，可以帮助改善幸福感。虽然许多研究表明冥想对患者和医疗保健专业人员都有好处，但向患者、医疗保健专业人员和第三方群体提供共同冥想的附加价值尚未得到评估。除了加强护理人员和患者之间的关系之外，向第三方（既不是护理人员也不是患者）开放冥想课程使患者能够摆脱疾病的耻辱感。我们之前进行了一项试点研究，该研究使用专门设计的方案验证了共同冥想的可行性和相关性。
方法/设计：IMPLIC-2 是一项双臂随机研究，旨在评估该冥想方案（根据试点研究进行了优化）的附加价值，特别是针对癌症患者（我们的目标人群）。有动机参加该计划但没有定期冥想且能够参加课程的人符合条件。该研究将包括 96 名参与者：16 名医疗保健专业人员、16 名第三方和 64 名患者。后者将随机分为两组：实验组（“共同”冥想）由 4 个 8 名患者、4 名医疗保健专业人员和 4 名第三方组成的混合小组组成，对照组（“患者”冥想）由 2 个 16 名患者组成的小组组成。将使用经过验证的问卷来衡量该计划的效果，特别是在生活质量、感知压力、自我效能感、正念和自我同情质量以及护理人员倦怠方面。在计划结束时，将测量参与者对生活质量变化和满意度的看法。还将使用补充的定性焦点小组方法来优化该计划的实施超出研究范围。
将改善肿瘤患者的幸福感。处理工作过度的护理人员将对他们与患者互动的方式产生有益的影响。此外，这三种人群之间的相遇将使他们能够以不同的方式看待他者，并通过促进集体人性来减轻痛苦。
NCT06041607，注册时间：2023 年 9 月 18 日。
2023 年 8 月 29 日发布的第 1.2 版。
